According to Hikma Pharmaceuticals, the FDA has concluded the dispute resolution process regarding HIkma’s ANDA for its generic version of the Advair fluticasone propionate/salmeterol DPI and has requested a new clinical study. The FDA issued a complete response letter to the ANDA in May 2017.
The company affirmed that it “remains committed to bringing this important product to the US market” and said that it anticipated the request for a new study, is prepared to initiate enrollment within a few weeks, and expects to submit data from the trial to the agency in 2019.
Hikma acquired US rights to the DPI, known as VR315, from Vectura, and Hikma’s subsidiary West-Ward Pharmaceuticals filed the ANDA in April 2016.
Read the Hikma Pharmaceuticals press release.
